BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS

    K Number: K082009 · Decision Aug 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    187
    Registration Numbers
    188
    Same Product Code
    503
    Applicant Total
    6
    Review Days
    30

    Basic Information

    Device Name
    HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
    K Number
    K082009
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HSINER CO., LTD.
    Date Received
    July 23, 2008
    Decision Date
    August 22, 2008
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by HSINER CO., LTD.

    K Number Device Name
    K102120 NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
    K091185 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
    K063268 CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
    K053466 HSINER RESUSCITATOR
    K052811 HSINER JET NEBULIZER, MODEL HS-31100